Owens & Minor Distribution, Inc. Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734
Brand
Owens & Minor Distribution, Inc.
Lot Codes / Batch Numbers
UDI-DI: 10680651417340 Lot Number: AH1215T51
Products Sold
UDI-DI: 10680651417340 Lot Number: AH1215T51
Owens & Minor Distribution, Inc. is recalling Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734 due to Potential open seal pouches compromising sterility resulting in the use of a non-sterile product in surgery could lead to patient infection. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential open seal pouches compromising sterility resulting in the use of a non-sterile product in surgery could lead to patient infection
Recommended Action
Per FDA guidance
Owens & Minor initiated recall by Voluntary Recall - EVENT # FCA-2022-009 letter dated 10/31/22 via email and Overnight mail. Letter states reason for recall, health risk and action to take: 1. REVIEW your inventory for the affected products. 2. SEGREGATE AND QUARANTINE all product on-hand per the Affected Product table above. 3. DESTROY or DISCARD the product per the facility s standard disposal procedure for surgical gowns. 4. COMMUNICATE this recall to staff to ensure awareness of the product issue. If the affected product identified above was further distributed, please ensure all end-users are appropriately notified of this recall notification. 5. RETURN the completed Recall Response Form and Certificate of Destruction Form to OMRA_RECALLS@owens-minor.com as soon as possible even if you have no current product inventory. If you have any questions, please email Caitlin Senter @ OMRA_RECALLS@owens-minor.com using the Event # FCA-2022-009 in the header of the response. This will ensure prompt response by the O&M Halyard, Inc, team.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IL, IN, WV
Page updated: Jan 10, 2026